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Blood Bag

by Mitra Industries Private Limited 99 variants

Ref Qu35MRSU-IIModel Model: Quadruple with RBC filter & PDS

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08906032180760 Basic UDI-DI 08906032180760UDI-DIDate2 Sep 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device Name
Blood Bag 350ml containing anticoagulant CPD as per USP, 49ml & RBC Preservative (SAGM) solution II, 78ml. With In-Line Leukodepletion filter for RBC.
Model / Reference
Model: Quadruple with RBC filter & PDS, Qu35MRSU-II
Primary DI / UDI-DI
08906032180760
Basic UDI-DI
B-08906032180760
EMDN Code
B0101020101 Donor blood collection quadruple bags, with filters and kits
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
IN-MF-000019525
Authorised representative
Advena Limited MT-AR-000000234

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Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No